As the medical community begins to understand and treat Female Sexual Dysfunction (FSD) numerous treatments are emerging. Dyspareunia is one form of FSD. Dyspareunia is caused by many anatomic and psychological problems. Some of the anatomic problems include pelvic surgery, vaginal stenosis and atrophy associated with aging or hormonal changes, radiation, transgender surgery, congenital abnormalities, and numerous other vaginal diseases. Psychological issues such as rape, abuse, anxiety, pelvic pain syndromes, and even lack of basic sexual education, can all have a devastating affect on women wanting to engage in vaginal intercourse, and are even more common than the anatomic causes of pain.
All of these causes, and others, are amenable to treatment by the vaginal dilation program of the present invention, such process being carefully designed for the individual patient by a therapist and/or physician.
Vaginal dilators are known in the prior art. For example, U.S. Pat. No. 5,681,340 discloses a vaginal dilator the length of which is adjustable. The device of the '340 patent is typical of what has been employed in the prior art for vaginal dilation. It is a rigid non-expandable dilator. The advantage of such dilators is that they are relatively inexpensive. However, they do not work with all patients.
U.S. Pat. No. 5,947,992 discloses an inflatable menstrual cup for preventing blood leakage. An inflatable member having an inflatable reservoir for collection of menstrual blood or organic fluids is inserted into the vaginal canal and inflated by pneumatic means so that it sealingly engages the vaginal wall. The pneumatic means can be provided by chemical reaction of components contained within the inflatable member.
U.S. Pat. Nos. 3,900,033 and 4,137,922 disclose an inflatable dilator for the cervical canal. The dilator comprises an envelope member having an enlarged bulbous portion on one end and a shield at the opposite end. The envelope member is inflatable with suitable gases such as carbon dioxide, or liquids such as saline, distilled water and the like. As is seen from the drawings, the dilator of these patents comprises an inserter tube provided with ports through which gas or liquid can be introduced through the tube into a relatively non-expansible envelope for the purpose of dilating the cervix.
U.S. Patent Application 20060200187 discloses a vaginal obturator device for preparing the vaginal area for delivery of a fetus during childbirth. The device comprises an elongated hollow shaft insertable in a vaginal opening during childbirth.
U.S. Pat. No. 4,228,801 discloses a dilator comprised of an at least partially hollow body made of an elastically deformable material defining a cavity that is hydro-pneumatically connected to a source of pressurized fluid by means of a substantially rigid duct. A valve is provided to control the hydro-pneumatic communication between the cavity and the source of pressurized fluid. When the dilator is positioned in situ, pressurized fluid is introduced through the duct and expands the body.
U.S. Pat. No. 1,735,519 discloses a nasal dilator designed so that principal dilation occurs at the distal end (i.e. the head or nose) of the instrument. To accomplish this the thickness of the wall is graduated, with the thinnest portion being disposed near the head.
Cervical dilators have also been reported in the literature. For example, MeDilator's “CerDilator”/“MD-12” uses a disposable inflatable catheter to dilate the cervix.
None of the above discussed prior art dilators is suitable for patient use of a dilator in the home in a method of treatment that allows for substantially pain-free vaginal dilation.